Probiotics in the Treatment of Irritable Bowel Syndrome

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01837472

390506

Details and patient eligibility

About

Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome (IBS), but few reports are available on the effects of multistrain probiotics and there are few reports available in this regard from our society. Thus, we investigated if probiotics are effective in our patients as well. We hypothesize that the multistrain probiotic Balance containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains, and Streptococcus thermophiles reduces the symptoms of irritable bowel syndrome.

Enrollment: 132 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 and 65
• diagnosis of IBS based on the Rome III criteria
• willingness to participate

Exclusion criteria

• receiving other probiotics compound during the study
• receiving antibiotics during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Treatment:

Drug: Probiotic

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo